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Prospective identification and causality evaluation of suspected adverse drug reactions in neonates
Neonates experience adverse drug reactions (ADRs), but under‐reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causali...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9328662/ https://www.ncbi.nlm.nih.gov/pubmed/32696451 http://dx.doi.org/10.1111/bcp.14485 |
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author | Roberts, Eve K. Hawcutt, Daniel B. Turner, Mark A. |
author_facet | Roberts, Eve K. Hawcutt, Daniel B. Turner, Mark A. |
author_sort | Roberts, Eve K. |
collection | PubMed |
description | Neonates experience adverse drug reactions (ADRs), but under‐reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causality by six assessors using three existing methods. Sixty‐three suspected ADR cases were identified in 35/193 neonates (18.1%). The proportion of suspected ADRs where the drug was prescribed “off‐label” was 30/68 (44.1%). When 34 cases were assessed for causality using three methods, global kappa scores of less than 0.3 for each tool suggested only “fair” inter‐rater reliability. Neonatal ADRs can be captured and occur from a variety of drugs affecting many organ systems. The current tools for assessing causality need to be adapted before they can reliably assess neonatal ADRs. |
format | Online Article Text |
id | pubmed-9328662 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93286622022-07-30 Prospective identification and causality evaluation of suspected adverse drug reactions in neonates Roberts, Eve K. Hawcutt, Daniel B. Turner, Mark A. Br J Clin Pharmacol Short Reports Neonates experience adverse drug reactions (ADRs), but under‐reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causality by six assessors using three existing methods. Sixty‐three suspected ADR cases were identified in 35/193 neonates (18.1%). The proportion of suspected ADRs where the drug was prescribed “off‐label” was 30/68 (44.1%). When 34 cases were assessed for causality using three methods, global kappa scores of less than 0.3 for each tool suggested only “fair” inter‐rater reliability. Neonatal ADRs can be captured and occur from a variety of drugs affecting many organ systems. The current tools for assessing causality need to be adapted before they can reliably assess neonatal ADRs. John Wiley and Sons Inc. 2020-09-07 2021-03 /pmc/articles/PMC9328662/ /pubmed/32696451 http://dx.doi.org/10.1111/bcp.14485 Text en © 2020 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Short Reports Roberts, Eve K. Hawcutt, Daniel B. Turner, Mark A. Prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
title | Prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
title_full | Prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
title_fullStr | Prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
title_full_unstemmed | Prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
title_short | Prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
title_sort | prospective identification and causality evaluation of suspected adverse drug reactions in neonates |
topic | Short Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9328662/ https://www.ncbi.nlm.nih.gov/pubmed/32696451 http://dx.doi.org/10.1111/bcp.14485 |
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